Randomized Phase III Trial of Neoadjuvant Chemotherapy Followed by Surgery Plus Adjuvant Chemotherapy Versus Surgery Plus Adjuvant Chemotherapy in Stage IB, IIA, IIB and T3N1 Non-small Cell Lung Cancer (ICON)
Inclusion Criteria:
- Histologically or cytologically proven NSCLC patients
- All patients must have:Clinical stage IB, IIA, IIB and T3N1 by mediastinoscopy, Chest
CT and PET-CT
- 18 year of ages or older
- ECOG performance status 0-1
- Uni-dimensionally measurable lesion by RECIST criteria
- No prior chemotherapy or radiotherapy for NSCLC
- Pre-operative FEV1 ≥ 2.0 L evaluated within 28 days
- Adequate bone marrow function: Hb > 9.0 g/dL, WBC ≥ 4,000/μL, platelet count ≥
100,000/μL
- Adequate liver and renal function: Total bilirubin < 2 x ULN, AST/ALT < 3 x ULN,
serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 60 mL/min
- Written informed consent
Exclusion Criteria:
- Superior sulcus tumor
- Prior malignancy except for adequately treated basal cell or squamous cell skin
cancer or in situ cervical cancer at least 5 years
- Uncontrolled systemic illness such as DM, CHF, unstable angina or arrhythmia
- Recent myocardial infarction within 6 months
- Patients with post-obstructive pneumonia or serious infection
- Pregnant or nursing women (Women of reproductive potential have to agree to use an
effective contraceptive method.)
- Patients with psychological problem